Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06207123
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-01-05
Brief Title:
A Study to Investigate LP-118 Ponatinib Vincristine and Dexamethasone in RelapsedRefractory Acute Lymphoblastic Leukemia ALL or Lymphoblastic Lymphoma LBL
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Phase III Study to Investigate the Combination of LP-118 Ponatinib Vincristine and Dexamethasone in RelapsedRefractory T-ALLLBL
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to learn more about LP-118 an experimental drug and its side effects and decide on acceptable doses The purpose of this study is to determine if LP-118 can be given safely with another medicine called ponatinib that is FDA-approved for the treatment of acute lymphoblastic leukemia
Detailed Description:
The purpose of this study is to learn more about LP-118 an experimental drug and its side effects and decide on acceptable doses The purpose of this study is to determine if LP-118 can be given safely with another medicine called ponatinib that is FDA-approved for the treatment of acute lymphoblastic leukemia
This study will investigate the combination of LP-118 and ponatinib at different dose levels to find the best doses that can be safely given to patients This means that enrolled subjects will receive progressive increasing or decreasing doses of these drugs until the maximally tolerated dose is determined All participants will also receive a standard of care chemotherapy combination consisting of the FDA approved drugs vincristine dexamethasone and intrathecal injection into the spinal canal also called spinal tap methotrexate This combination is standard of care for relapsed T-ALLLBL
This study will investigate the combination of LP-118 and ponatinib at different dose levels to find the best doses that can be safely given to patients This means that enrolled subjects will receive progressive increasing or decreasing doses of these drugs until the maximally tolerated dose is determined All participants will also receive a standard of care chemotherapy combination consisting of the FDA approved drugs vincristine dexamethasone and intrathecal injection into the spinal canal also called spinal tap methotrexate This combination is standard of care for relapsed T-ALLLBL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None